Study Budget Development 2013

Transcription

1 Study Budget Development 2013 Putting a budget together.where do you start? Presented by Phyllis Klein, RN, CCRC, BSN Director, Regulatory, Compliance & Support Center for Clinical Studies Washington University in St. Louis (314)

2 Objectives Why prepare a budget? To understand: Where the money comes from to pay the coordinator s salary Where the money comes from to pay for study procedures

3 Objectives (continued) Why your study should not bill two sources for the same procedure Why patients do not get billed for something the study should provide for free Making sure all the paperwork says the same thing

4 Why prepare a budget? Independent review of local costs to conduct this research Why trust the sponsor s estimate? Academic Center s costs are notoriously more expensive than sponsor estimates An opportunity to compare costs, and see if the offered budget is adequate

5 Have you ever wondered How the funds are generated to pay the coordinator s salary? Whether you are the research coordinator or PI, think about what you do for this study: Are you preparing for a new research study? Screening and enrolling patients? Following those patients at each study required visit? Preparing IRB applications, or amendments, or filing IND safety reports?

6 Who Pays you Your employer obviously pays you but, who provides the money? Obviously, the PI or the department pays you How does the department justify your salary? Where does the money come from? Industry sponsors? NIH/federal government groups? Foundations?

7 Who pays you Have you worried about staff cuts (especially when grants dry up)? Would you like to share the responsibility in maintaining your position? In what way can you prove that you are worth your salary?

8 Being Prepared! Full time employee = 2,080 hours/year Less hours/vacation (22 days= Less unverified sick time (5 days)= - 40 Less paid holidays (8 days)= ,800 actual workable hours /year Less breaks, , etc.@1 hr per work day= -208 Yields: 1592 realistic work hours/year Less mandatory training, meetings, etc. =? Less inefficiencies (times when work is slow)

9 Figuring your hourly rate Take your annual salary Add 30% for all benefits (if academia) Divide by 1592 realistic workable hours For instance: $50,000 annual salary Plus 30% (benefits) or $15,000=$65,000 Divide by 1592 hours=$ per hour (This # does not allow for inefficiencies) Now, you have your hourly rate!

10 Study Budget Development Now that you have estimated the hourly rate, getting started on the study budget is next: Print out the schedule of events It s obvious that you need to read the protocol in detail takes notes! Determine what services for which you need to obtain pricing Are any of these services considered standard of care (SOC)? Identify those that are needed for the research only

11 Study Budget Development Compare the schedule of events with the protocol requirements in the protocol The protocol does not always match the grid! Determine how long you will need to be with the patient at each visit What paperwork needs to be done when the patient leaves?

12 Study Budget Development Affix a cost for each studyrelated procedure based on who is involved and the time it takes. Obtain a price quote with a research discount for those procedures done by others

13 Study Budget Development Will patient reimbursements be a factor in your budget? Patient stipends Parking stamp fees Mileage Taxi s fees Hotel charges

14 SOC versus Investigational Charges in your study budget cannot be billed to another source If standard care dictates, and the procedure will be paid by patient insurance or Medicare, then you cannot have the cost in your study budget If the informed consent says the patient will not pay for certain services, then they cannot be charged, and neither can their insurance company or Medicare

15 Patient Costs Patients are responsible for any co-pays or deductibles that are part of their insurance plan if the procedure is billed to insurance We CANNOT reimburse the cost of the copays or deductibles even if the study sponsor wants to provide this funding for us If covered by the study budget, you MUST pay for the entire procedure from the study funds you cannot allow the patient/insurance company or Medicare to cover even part of the cost Most institutions have a mechanism in place to offer research discounts for study procedures and professional fees for studyfunded procedures

16 Sample Clinic Budget Study: A12345 Drug: CP Sponsor: Pfizer, Inc SITE: 104 PI: Gregory House, MD Date: 1/7/2013 Site: Center for Clinical Studies Report Date: 2/05/2013 Chart showing a sample clinical budget.

17 Sample Clinic Budget Chart showing sample clinic budget

18 Start-up fees/invoiced Items Don t forget your one-time costs IRB submission fees IRB Preparation/Regulatory fee Research Pharmacy fees Document Archiving Storage fee On all amounts in your study budget add OVERHEAD!

19 Suggested Fees These are examples of fees we try to recover in the budgets we negotiate: Administrative Support CCS - $1,000 (For budget only, includes OH) HRPO Initial Submission $2,500 + OH Initial IRB Prep & Regulatory $3,500 Annual HRPO Renewals $1,500/yr + OH Annual IRB Prep & Regulatory $1,000 Amendment Prep & Processing $ 500 each Expedited HRPO Review $1,250 + OH

20 Suggested Fees Med Storage $500-$1000 BJH Research Pharmacy costs (Initial and annual fees + OH) Advertising $5,000 Recruitment $5,000 Document Archiving $1,000 For up to 15 years

21 Suggested Fees Patient Stipend sponsor s amt $ 50 Parking stamp - $ 15 day CRF Completion/SM $60-$75/hr Be sure to include enough hours for the coordinator. Sometimes the paperwork may take 2 hours per patient visit. Sometimes, there is an hour before the visit to consider, too!

22 Suggested fees Phlebotomy $60-$75/hour RN or $30/med tech Safety Labs $60-$75/hour RN or $30/med tech Lab Processing $60-$75/hour RN or $30/med tech (Refer to the hourly amount you calculated)

23 Suggested Fees Medication dispensing $60- $75/hour Med accountability $60-$75/hour Don t forget the per patient BJH pharmacy charges in addition to the person administering the drug! Don t forget any prophylactic medications that are not supplied by the sponsor

24 Suggested Fees When figuring the fee to do an infusion or ECG, remember the costs of equipment maintenance (these expenses should be included in the cost of the procedure): For example, we allow: IV Pump use & supplies, per infusion $25 EKG machine $25

25 Suggested Fees Monitoring Visits (with Sponsor s add ~½ hour per patient visit (e.g. $30-$40 per visit) Sponsors will tell you that these expenses are part of the cost of doing business, but you need to account for this somewhere! Usually when monitors come, they monitor more than one chart so the ½ hours you add-in will add-up to cover your time overall

26 Suggested Fees PI fee - $50 per study visit, totaling $500-1,000 per patient unless PI specifies something different (to oversee study) If in doubt, ask your principal investigators what amounts they would like to include Sub PI fee, if applicable - $

27 Suggested Fees Regulatory work, by the hour, $60-75/hour CHART REVIEW, by the chart, $35 per patient (FYI: ratio of 3 screened to each enrolled)

28 Study Budget Development Industry sponsor s usually have a little wiggle room on their budgets It used to be about 30% before they need approval from the next level up! With the cost cuts and Sunshine Act, it is now less Don t be afraid to ask for a little more, all they can say is no!

29 Contacts - WU In order to get the cost of professional fees for your study procedures, someone needs to call the department providing the service for pricing We have no central area for WU budget pricing at present The FPP has agreed to a research rate for professional fees of 1.8 times the 2007 Medicare rate for industry sponsored studies

30 Federally Funded Studies These studies need to be budgeted at your cost: Any studies funded by: NIH Collaborative Groups funded by NIH Department of Defense Center for Disease Control

31 Federally funded studies: What is cost? For labor: it is the salary plus benefits for an employee many times you name the employee If this is the case, you will budget for an FTE (full time equivalent) of an individual s salary

32 Determining Costs: Procedures & Supplies Many times, there are two different rates for procedures - industry & federal When requesting costs for a federally funded study, tell your contact that the study is federally funded so that they can provide you with the correct price quote. This applies to quotes for labs, x-rays, hospital procedures, room rates, etc.

33 Overhead The overhead rate for federally funded studies may vary depending on the study You will need to contact Grants & Contracts for this information The overhead rate for industry sponsored studies at WU is : 26% dean s overhead +5-11% department overhead, if applicable

34 Study Budget Development Questions?